StridorNCT06212037
POCUS of the Pediatric Critical Airway
An observational study of Stridor, run by Northwell Health at 1 site in United States.
Trial summary
The goal of this observational study is to assess the laryngeal air column width difference measurement on point of care ultrasound as a predictive indicator of post-extubation stridor in the pediatric critical care population. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Stridor
- What is being tested?
- Point of Care Ultrasound
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- Child, Adult
Study population: Projected 150 patients. The CCMC PICU is a 37-bed regional referral center with approximately 2500 admissions annually. Recruitment can be accomplished while allowing for loss due to exclusions, timing, or non-consent. Approximately 350 children are extubated each year.
Who may be able to join
- 0 to 18 years
- Mechanical ventilation with an endotracheal tube
- Patient on or approaching extubation readiness
Who cannot join
- Age >18 years
- Current tracheostomy in place
- History of recent upper airway obstruction or vocal cord paralysis
- Patients who cannot have their neck in a slightly hyperextended position due to injury or ligament laxity
Trial locations and contacts
1 site in 1 country.
April Slamowitz, MD contact
United States1 site, 1 recruiting
- Recruiting
Cohen Children's Medical Center
Queens, New York, 11040
Kristina Murphy, DO, kmurphy16@northwell.edu
April Slamowitz, MD, aslamowitz@northwell.edu
About this study
Official title: POCUS of the Pediatric Critical Airway, A Prospective Clinical Observational Study
The goal of this observational study is to assess the laryngeal air column width difference measurement on point of care ultrasound as a predictive indicator of post-extubation stridor in the pediatric critical care population.
The main question it claims to answer is: In pediatric intensive care unit patients, can point of care ultrasound measurements of laryngeal air column width difference be used as a sensitive and specific tool to predict post extubation stridor in comparison to standard qualitative and quantitative evaluations?
Participants will be enrolled when they are on or approaching extubation readiness. At this time, an ultrasound of their airway will be performed by the investigators and the laryngeal air column width difference will be recorded.
Read the detailed description
The pediatric airway is markedly different front that of the adult airway, with unique anatomical challenges that can make endotracheal extubation of the pediatric airway more complicated. Pediatric patients are sensitive to small changes in diameter and patients who have been intubated may experience laryngeal edema. This laryngeal edema is multifactorial, but in large part is caused by mechanical pressure or irritation from the endotracheal tube itself. Mucosal ulcerations and laryngeal edema occur in almost all patients intubated for greater than four days. In pediatrics, the laryngeal edema from endotracheal intubation can lead to upper airway obstruction (UOA) with the development of post extubation stridor (PES), and often, respiratory distress. Early identification of patients who are at high risk for PES is critical, as it allows for proper preparation and prevention of complications.
The rates of PES have been estimated between 5% and 54%, widely varied in the literature. Some factors that have been identified as predictive of PES include young age, female gender, previous history of airway difficulties, longer intubation duration, elevated cuff pressure, incorrect endotracheal tube size, airway infection, traumatic intubation, repeated intubation attempts, prolonged intubation, aggressive tracheal aspiration, increased tube mobility, and unintentional extubations.
Recently, ultrasound has been used to help predict those patients who may be at risk for PES. Currently, cuff leak tests have been widely used to predict upper airway patency and are currently standard of care in Pediatric Intensive Care Units across the country, however, the positive predictive value of this test has consistently shown to be low. With ultrasound, a measurement of the laryngeal air column width can be used to predict patients who will develop PES. An observational study done in 2018 at a single, tertiary pediatric hospital showed that laryngeal ultrasound done by experienced ultrasonographers and radiologists prior to extubation could predict patients who would develop PES.
In critical care, there is a significant need to decrease PES rates and POCUS could provide a rapid, reliable, and sensitive assessment of the pediatric patient who is at risk for PES and its complications.
The investigators hypothesize that patients with smaller laryngeal air column width differences on POCUS will have a higher likelihood of developing PES.
Ultrasound measurements will be completed as soon as the patient is deemed to perform extubation readiness assessments, as determined by the attending pediatric intensivist. The ultrasound will be performed within 1 to 12 hours prior to extubation, alongside the Respiratory Therapist evaluation of cuff pressure, per standard unit protocol.
A high frequency linear phased array probe will be used for obtaining the images with a General Electric (GE) ultrasound machine. Prior to obtaining images, the endotracheal tube will be suctioned per unit standard nursing protocol. Additionally, oral and pharyngeal secretions will be gently suctioned. The linear probe will then be placed on the cricothyroid membrane with a transverse view of the larynx. The scanning plane will contain multiple landmarks, including the vocal cords, the tracheal cartilage, and possibly, the arytenoid cartilages. The laryngeal air column width will then be measured with the endotracheal tube cuff inflated and deflated. The laryngeal air column width difference is the difference between the balloon inflated width minus the balloon deflated width.
Three measurements of the laryngeal air column width difference will be taken and averaged for a final value. The presence of PES will be defined by the administration of racemic epinephrine within 6 hours of extubation, as detemined by the extubating physician, who is not a part of the study team.
- Conditions
- Stridor
- Being tested
- Point of Care Ultrasound
- Medical subject headings
- Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of Care UltrasoundDiagnostic test
Point of Care Ultrasound will be performed on all subjects and their laryngeal air column width difference will be calculated. The patients will be followed after extubation and the presence/absence of post extubation stridor will be recorded.
What is being measured
The primary outcome is the main question the study is designed to answer.
Laryngeal Air Column Width Difference Measurement in Patients Who Develop Post-Extubation Stridor
The laryngeal air column width difference (LACWD) will be measured on patients prior to extubation and this measurement will be used to predict the likelihood of development of post-extubation stridor (PES, a physiological outcome measure). PES will be determined by the presence or absence of a high-pitched inspiratory sound heard by the evaluating physician or by the administration of inhaled racemic epinephrine within 0-6 hours of extubation. This information will be documented by the extubating physician (not a part of the study team) in the electronic medical record. There will not be repeated measures, the presence or absence of stridor in the six hours following extubation will be captured as a categorical value (yes or no).
Measured: 6 hours following extubation
Secondary outcomes (1)
Number of Patients Who Develop PES with Cuff Pressures Greater than 20cm H20 and Relationship to LACWD
Cuff pressures will be measured in cmH20 using a standard manometer on patients prior to extubation and this measure will be used to predict the likelihood of development of PES. PES will be determined by the presence or absence of a high-pitched inspiratory sound heard by the evaluating physician with or without respiratory distress or by the requirement/administration of inhaled racemic epinephrine within 0-6 hours of extubation. This information will be documented by the extubating physician (not a part of the study team) in the electronic medical record. There will not be repeated measures, the presence or absence of stridor in the six hours following extubation will be captured as a categorical value (yes or no).
Measured: 6 hours following extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Dec 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StridorStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristina Murphy, DO, Principal investigator, Northwell Health, Cohen Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212037
- Sponsor's protocol ID
- 23-0649
- Status last verified
- Jan 2024
- First submitted
- 15 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhargava V, Rockwell NA, Tawfik D, Haileselassie B, Petrisor C, Su E. Prediction of Difficult Laryngoscopy Using Ultrasound: A Systematic Review and Meta-Analysis. Crit Care Med. 2023 Jan 1;51(1):117-126. doi: 10.1097/CCM.0000000000005711. Epub 2022 Nov 3.
PubMed 36519985Burton L, Bhargava V, Kong M. Point-of-Care Ultrasound in the Pediatric Intensive Care Unit. Front Pediatr. 2022 Feb 1;9:830160. doi: 10.3389/fped.2021.830160. eCollection 2021.
PubMed 35178366Daniel SJ, Bertolizio G, McHugh T. Airway ultrasound: Point of care in children-The time is now. Paediatr Anaesth. 2020 Mar;30(3):347-352. doi: 10.1111/pan.13823. Epub 2020 Jan 20.
PubMed 31901216Kimura S, Ahn JB, Takahashi M, Kwon S, Papatheodorou S. Effectiveness of corticosteroids for post-extubation stridor and extubation failure in pediatric patients: a systematic review and meta-analysis. Ann Intensive Care. 2020 Nov 18;10(1):155. doi: 10.1186/s13613-020-00773-6.
PubMed 33206245Jaber S, Chanques G, Matecki S, Ramonatxo M, Vergne C, Souche B, Perrigault PF, Eledjam JJ. Post-extubation stridor in intensive care unit patients. Risk factors evaluation and importance of the cuff-leak test. Intensive Care Med. 2003 Jan;29(1):69-74. doi: 10.1007/s00134-002-1563-4. Epub 2002 Nov 22.
PubMed 12528025Venkategowda PM, Mahendrakar K, Rao SM, Mutkule DP, Shirodkar CG, Yogesh H. Laryngeal air column width ratio in predicting post extubation stridor. Indian J Crit Care Med. 2015 Mar;19(3):170-3. doi: 10.4103/0972-5229.152763.
PubMed 25810614
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POCUS of the Pediatric Critical Airway, A Prospective Clinical Observational Study
- ClinicalTrials.gov ID
- NCT06212037
- Acronym / sponsor ID
- 23-0649
- Conditions
- Stridor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to assess the laryngeal air column width difference measurement on point of care ultrasound as a predictive indicator of post-extubation stridor in the pediatric critical care population.
The main question it claims to answer is: In pediatric intensive care unit patients, can point of care ultrasound measurements of laryngeal air column width difference be used as a sensitive and specific tool to predict post extubation stridor in comparison to standard qualitative and quantitative evaluations?
Participants will be enrolled when they are on or approaching extubation readiness. At this time, an ultrasound of their airway will be performed by the investigators and the laryngeal air column width difference will be recorded.
Detailed description
The pediatric airway is markedly different front that of the adult airway, with unique anatomical challenges that can make endotracheal extubation of the pediatric airway more complicated. Pediatric patients are sensitive to small changes in diameter and patients who have been intubated may experience laryngeal edema. This laryngeal edema is multifactorial, but in large part is caused by mechanical pressure or irritation from the endotracheal tube itself. Mucosal ulcerations and laryngeal edema occur in almost all patients intubated for greater than four days. In pediatrics, the laryngeal edema from endotracheal intubation can lead to upper airway obstruction (UOA) with the development of post extubation stridor (PES), and often, respiratory distress. Early identification of patients who are at high risk for PES is critical, as it allows for proper preparation and prevention of complications.
The rates of PES have been estimated between 5% and 54%, widely varied in the literature. Some factors that have been identified as predictive of PES include young age, female gender, previous history of airway difficulties, longer intubation duration, elevated cuff pressure, incorrect endotracheal tube size, airway infection, traumatic intubation, repeated intubation attempts, prolonged intubation, aggressive tracheal aspiration, increased tube mobility, and unintentional extubations.
Recently, ultrasound has been used to help predict those patients who may be at risk for PES. Currently, cuff leak tests have been widely used to predict upper airway patency and are currently standard of care in Pediatric Intensive Care Units across the country, however, the positive predictive value of this test has consistently shown to be low. With ultrasound, a measurement of the laryngeal air column width can be used to predict patients who will develop PES. An observational study done in 2018 at a single, tertiary pediatric hospital showed that laryngeal ultrasound done by experienced ultrasonographers and radiologists prior to extubation could predict patients who would develop PES.
In critical care, there is a significant need to decrease PES rates and POCUS could provide a rapid, reliable, and sensitive assessment of the pediatric patient who is at risk for PES and its complications.
The investigators hypothesize that patients with smaller laryngeal air column width differences on POCUS will have a higher likelihood of developing PES.
Ultrasound measurements will be completed as soon as the patient is deemed to perform extubation readiness assessments, as determined by the attending pediatric intensivist. The ultrasound will be performed within 1 to 12 hours prior to extubation, alongside the Respiratory Therapist evaluation of cuff pressure, per standard unit protocol.
A high frequency linear phased array probe will be used for obtaining the images with a General Electric (GE) ultrasound machine. Prior to obtaining images, the endotracheal tube will be suctioned per unit standard nursing protocol. Additionally, oral and pharyngeal secretions will be gently suctioned. The linear probe will then be placed on the cricothyroid membrane with a transverse view of the larynx. The scanning plane will contain multiple landmarks, including the vocal cords, the tracheal cartilage, and possibly, the arytenoid cartilages. The laryngeal air column width will then be measured with the endotracheal tube cuff inflated and deflated. The laryngeal air column width difference is the difference between the balloon inflated width minus the balloon deflated width.
Three measurements of the laryngeal air column width difference will be taken and averaged for a final value. The presence of PES will be defined by the administration of racemic epinephrine within 6 hours of extubation, as detemined by the extubating physician, who is not a part of the study team.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Projected 150 patients. The CCMC PICU is a 37-bed regional referral center with approximately 2500 admissions annually. Recruitment can be accomplished while allowing for loss due to exclusions, timing, or non-consent. Approximately 350 children are extubated each year.
Key inclusion criteria (3 listed)
- 0 to 18 years
- Mechanical ventilation with an endotracheal tube
- Patient on or approaching extubation readiness
Key exclusion criteria (4 listed)
- Age >18 years
- Current tracheostomy in place
- History of recent upper airway obstruction or vocal cord paralysis
- Patients who cannot have their neck in a slightly hyperextended position due to injury or ligament laxity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point of Care UltrasoundPoint of Care Ultrasound will be performed on all subjects and their laryngeal air column width difference will be calculated. The patients will be followed after extubation and the presence/absence of post extubation stridor will be recorded. | Diagnostic test | – |
Primary outcome
Laryngeal Air Column Width Difference Measurement in Patients Who Develop Post-Extubation Stridor
Time frame: 6 hours following extubation
The laryngeal air column width difference (LACWD) will be measured on patients prior to extubation and this measurement will be used to predict the likelihood of development of post-extubation stridor (PES, a physiological outcome measure). PES will be determined by the presence or absence of a high-pitched inspiratory sound heard by the evaluating physician or by the administration of inhaled racemic epinephrine within 0-6 hours of extubation. This information will be documented by the extubating physician (not a part of the study team) in the electronic medical record. There will not be repeated measures, the presence or absence of stridor in the six hours following extubation will be captured as a categorical value (yes or no).
1 secondary outcome
Number of Patients Who Develop PES with Cuff Pressures Greater than 20cm H20 and Relationship to LACWD
Time frame: 6 hours following extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Background: PubMed 36519985Bhargava V, Rockwell NA, Tawfik D, Haileselassie B, Petrisor C, Su E. Prediction of Difficult Laryngoscopy Using Ultrasound: A Systematic Review and Meta-Analysis. Crit Care Med. 2023 Jan 1;51(1):117-126. doi: 10.1097/CCM.0000000000005711. Epub 2022 Nov 3.
- Background: PubMed 35178366Burton L, Bhargava V, Kong M. Point-of-Care Ultrasound in the Pediatric Intensive Care Unit. Front Pediatr. 2022 Feb 1;9:830160. doi: 10.3389/fped.2021.830160. eCollection 2021.
- Background: PubMed 31901216Daniel SJ, Bertolizio G, McHugh T. Airway ultrasound: Point of care in children-The time is now. Paediatr Anaesth. 2020 Mar;30(3):347-352. doi: 10.1111/pan.13823. Epub 2020 Jan 20.
- Background: PubMed 33206245Kimura S, Ahn JB, Takahashi M, Kwon S, Papatheodorou S. Effectiveness of corticosteroids for post-extubation stridor and extubation failure in pediatric patients: a systematic review and meta-analysis. Ann Intensive Care. 2020 Nov 18;10(1):155. doi: 10.1186/s13613-020-00773-6.
- Background: PubMed 12528025Jaber S, Chanques G, Matecki S, Ramonatxo M, Vergne C, Souche B, Perrigault PF, Eledjam JJ. Post-extubation stridor in intensive care unit patients. Risk factors evaluation and importance of the cuff-leak test. Intensive Care Med. 2003 Jan;29(1):69-74. doi: 10.1007/s00134-002-1563-4. Epub 2002 Nov 22.
- Background: PubMed 25810614Venkategowda PM, Mahendrakar K, Rao SM, Mutkule DP, Shirodkar CG, Yogesh H. Laryngeal air column width ratio in predicting post extubation stridor. Indian J Crit Care Med. 2015 Mar;19(3):170-3. doi: 10.4103/0972-5229.152763.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
April Slamowitz, MD contact
Kristina Murphy, DO principal investigator
Northwell Health, Cohen Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stridor, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristina Murphy, DO (516-562-1593, kmuprhy16@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laryngeal Air Column Width Difference Measurement in Patients Who Develop Post-Extubation Stridor (time frame: 6 hours following extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06212037, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.